blinded randomized placebo-controlled study efficacy and safety of injectafer in id patients with fibromyalgia

Conditions: Iron Deficiency; Fibromyalgia

Summary: this study investigates the efficacy and safety of an iv iron injectafer in the treatment of iron deficient patients with fibromyalgia. eligible subjects will be randomized in a 1:1 ratio to receive injectafer or placebo on days 0 and 5. all treated subjects will be followed for efficacy and safety for 42 days.

this is a blinded, randomized, placebo-controlled study. all subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. eligible subjects will be randomized in a 1:1 ratio to receive injectafer or placebo on days 0 and 5. all treated subjects will be followed for efficacy and safety for 42 days. subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. the subject's participation in the study will be for approximately 42 days from day 0.

Eligibility criteria:
inclusion criteria: * male or female subject's ≥ 18 years of age, able to give informed consent to the study. * fibromyalgia diagnosis based on the 2011 modification of the american college of rheumatology (acr) 's 2010 preliminary criteria for diagnosing fibromyalgia (2011modcr) * a baseline score ≥ 60 on the fiqr * subject's current medications to treat fibromyalgia, including pain medicines, anti-depressants, sleep medications must be on a stable dose for at least 30 days. * subject's current narcotic medication must be on a stable dose for at least 30 days prior to randomization * subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility. exclusion criteria: * parenteral iron use within 4 weeks prior to screening. * history of \> 10 blood transfusions in the past 2 years. * anticipated need for blood transfusion during the study. * known hypersensitivity reaction to any component of injectafer® (ferric carboxymaltose). * current or acute or chronic infection other than viral upper respiratory tract infection * malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years). * active inflammatory arthritis (e.g. rheumatoid arthritis, sle). * pregnant or lactating women. * severe peripheral vascular disease with significant skin changes. * seizure disorder currently being treated with medication. * baseline ferritin ≥ 50 ng/ml. * baseline tsat ≥ 20%. * history of hemochromatosis or hemosiderosis or other iron storage disorders. * known positive hepatitis with evidence of active disease. * hemoglobin greater than the upper limit of normal. * calcium or phosphorous outside the normal range. * known positive hepatitis b antigen (hbsag) or hepatitis c viral antibody (hcv) with evidence of active hepatitis (i.e., ast/alt greater than the upper limit of normal). * known positive hiv-1/hiv-2 antibodies (anti-hiv) * received an investigational drug within 30 days before randomization. * chronic alcohol or drug abuse within the past 6 months. * any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk. * subject unable to comply with the study requirements.